Low Dose Extended-release Epidural and Lumbar Plexus Block Compared to Lumbar Plexus Block for Total Hip Resurfacing

Low Dose Extended-release Epidural Morphine in Conjunction With Lumbar Plexus Block Versus Lumbar Plexus Block Alone for Total Hip Resurfacing Arthroplasty: A Randomized Controlled Trial.

At Wake Forest University, the investigators have been using Extended Release Epidural Morphine (EREM), since late 2004, as part of multimodal analgesia in patients having gynecologic surgeries and hip arthroplasties.

Hypothesis:

In patients undergoing a Birmingham total hip arthroplasty (BHA), low dose EREM in conjunction with lumbar plexus block (LPB) will be better than lumbar plexus block alone in increasing proportion of patients who meet discharge criteria within 24 hours.

Study Overview

• Status: Terminated
• Conditions: Hip Arthroplasty
• Intervention / Treatment: Drug: Extended Release Epidural Morphine (EREM); Drug: Placebo

Detailed Description

Extended release epidural morphine (EREM, DepoDur®: Endo Pharmaceuticals, Chadds Ford PA) has been studied and increasingly utilized as a method to allow for the improved post-operative analgesia of epidural analgesia without infusions.

At Wake Forest University, the investigators have been using EREM, since late 2004, as part of multimodal analgesia in patients having gynecologic surgeries and hip arthroplasties. The investigators initially decreased our dosages from those recommended (15 mg for lower extremity surgery and 10-15 mg for abdominal surgery), because side effects (nausea, vomiting and hypotension) were felt to be limiting to recovery. The investigators now use 4-7.5 mg in most patients, with 7.5 mg being the exception and have achieved better results. For hip arthroplasties, the investigators currently use 4-5 mg and have performed two retrospective chart reviews on this use; both suggesting that this approach is efficacious. However, these doses have not been studied in a prospective, randomized, double blind trial. The investigators would like to evaluate the efficacy of this dose of EREM used as part of a multimodal regimen. The investigators will compare EREM 4 mg with lumbar plexus block versus lumbar plexus block alone, (providing the rest of our multimodal approach for both patients).

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Baptist Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A primary unilateral Birmingham hip arthroplasty
• Men and women 18-65 years

Exclusion Criteria:

• Refusal of regional anesthesia
• Laboratory evidence of coagulopathy (platelet count less than 100,000 cells/microliter of blood, prothrombin time greater than 12.1 seconds, partial thromboplastin time greater than 30 seconds, or international normalized ratio of greater than 1.5)
• Allergy to morphine
• Obstructive sleep apnea
• Body mass index (BMI) greater than 40 kg/m2
• Pregnant or lactating
• Severe renal or hepatic disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Extended Release Epidural Morphine; Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline	Drug: Extended Release Epidural Morphine (EREM); A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline; Other Names: Depodur
PLACEBO_COMPARATOR: Placebo Group; The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush	Drug: Placebo; A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush; Other Names: sodium chloride; preservative free normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Length of Hospital Stay After Surgery	From surgery day to hospital discharge, up to 4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Opioid Consumption	Postoperatively, the patients were observed in the post anesthesia care unit (PACU) until regression of sensory levels is demonstrated. They were provided an intravenous (IV) Patient Controlled Analgesia (PCA) and instructions in its use. Morphine 1mg/ml at standard PCA settings (1.5 ml dose, 10 minute lockout interval, 6 ml hourly limit, no basal infusion) were used for postoperative analgesia until discharge plans were made. (Morphine doses were increased in 0.5ml dose increments if the patients were not achieving adequate analgesia.)	96 hours
Patient Satisfaction Score	Verbal satisfaction scores (0-10), higher scores represent better outcomes. Scores will be obtained from patients for 96 hours after surgery.	96 hours
Distance Walked at Walking Test	Distance walked at walking test. Longer distance walked represent better outcomes	96 hours
Verbal Pain Scores Post-gait	Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest.	1 day post surgery
Verbal Pain Scores Post-gait	Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest.	2 Days Post Surgery
Verbal Pain Scores Post-gait	Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest.	3 Days Post Surgery
Verbal Pain Scores Post-gait	Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest.	4 Days Post Surgery

Collaborators and Investigators

• Sponsor: Wake Forest University
• Collaborators: EKR Therapeutics, Inc
• Investigators: Principal Investigator: Pamela C Nagle, M.D., Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ACTUAL): March 1, 2013
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: July 2, 2009
• First Submitted That Met QC Criteria: July 7, 2009
• First Posted (ESTIMATE): July 8, 2009

Study Record Updates

• Last Update Posted (ACTUAL): September 12, 2018
• Last Update Submitted That Met QC Criteria: September 10, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: hip arthroplasty; hip resurfacing
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: IRB00006969

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No